In order for our site to display correctly you will need a newer version of your web browser.

Please note that this is not intended to be an exhaustive list of browsers that support web standards, nor a test of browser compliance, nor a side-by-side comparison of various manufacturers’ browsers.

Protocol

Diseases

This study is designed to treat all patients with newly diagnosed medulloblastoma including any variant. Therapy of medulloblastoma has been based only on extent of disease (clinical risk), however recent studies show that there are different types of medulloblastoma also known as molecular subgroups. These are identified using molecular markers found in these tumors. Different molecular sub-groups have been found to respond differently to treatment. The therapy the participant receives will be based on the tumor’s molecular sub-group (molecular risk) and the extent of disease (clinical risk group).

All participants will be treated with risk-adapted radiation therapy and adjuvant chemotherapy. Participants who have a lower risk of disease recurrence will be treated with lower doses of radiation therapy thereby decreasing exposure and potential severity of side effects. Some participants will get targeted therapy based on their specific biology (SHH) and others who have a higher risk of disease recurrence will be treated with novel agents in addition to standard treatment. Please see the graph below showing the stratification based on molecular and clinical risk:

There are three parts to this study:

Screening phase-tests done before treatment starts.

Treatment phase-radiation and chemotherapy and tests done during protocol treatment.

To estimate the progression free and overall survival distributions of Non-WNT Non-SHH medulloblastoma patients treated on Strata N2 and N3 with 3 cycles of pemetrexed and gemcitabine in addition to 4 cycles of conventional adjuvant chemotherapy and compare the progression-free and overall survival distributions to molecularly and clinically matched historical controls from SJMB03 separately for each stratum.

To evaluate the feasibility and toxicity of adding pemetrexed and gemcitabine to adjuvant chemotherapy regimen of intermediate and high risk Non-WNT Non-SHH medulloblastoma patients (Strata N2 and N3)

To evaluate the feasibility and toxicity of oral maintenance therapy with the targeted SHH inhibitor (vismodegib) after conventional adjuvant chemotherapy regimen is complete.

To estimate the cumulative incidence of local disease failure at 2 and 5 years based on treatment regimen, strata, and clinical and treatment factors.

Eligibility Criteria, among others, include:

Histological diagnosis of Medulloblastoma including any variant and posterior fossa PNET

Participant must be age ≥ 3 years and < 22 years at the time of diagnosis.

Participant has had no previous radiotherapy or chemotherapy or other brain tumor directed therapy other than corticosteroid therapy and surgery.

Participant will begin protocol treatment within 36 days of definitive surgery.

Participant does not have any clinically significant medical disorder that could compromise their ability to tolerate protocol therapy or would interfere with the study procedures or results history.

For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.